Nkwakọ ngwaahịa aluminom foil: Oke dị oke egwu yana mmetụta oke oke ma ọ bụ ịdị arọ na ntinye ahụike.

ECO-a. Ndubata: Ndokwa ịdị arọ na ọrụ isi nke nkwakọ ngwaahịa aluminom a na-akụnye

N'ubi ngwaọrụ ahụike a na-akụnye (E.G., mkpuchi maka stent na-ekpochapụ ọgwụ, ndị na-ebu maka sistemụ nnyefe ọgwụ na-akwado subcutaneous, na electromagnetic shielding layers maka implantable sensọ-niile mere si Nkwakọ ngwaahịa aluminom foil), nke a pụrụ iche aluminom foil ga-n'out oge izute atọ isi chọrọ: “arụmọrụ mma,” “nkwado ihe owuwu,” na “na vivo kwụsie ike.” Njikwa ọkpụrụkpụ ya (ya na nkenke ọkwa micron) bụ ihe ngosi nka dị oke egwu. N'adịghị ka ulo oru foil aluminum (na-abụkarị 50-200μm), Ihe mgbochi akụrụngwa ọgwụ a kwesịrị itule “ịhịa aka n'ahụ” (imeghari ka ọ dị ntakịrị mkparụ ọrụ) na “n'ibu Njirimara” (iguzogide nrụgide vivo). Nke mbụ na nke mbụ, ụkpụrụ ụlọ ọrụ dị ugbu a (dị ka YBB 00152023 Aluminom na Aluminom Alloy Foils maka Ọgwụ Ọgwụ na ISO 13028-2 Ngwa ọla maka akụrụngwa enwere ike ịkụnye – Nkewa 2: Aluminom na aluminom Alloys) kọwaa n'ụzọ doro anya na ọkpụrụkpụ nso nke a pụrụ iche foil, na foil ga-agaferịrị USP <88> ule biocompatibility na ISO 10993-12 na vivo nkwenye nbibi.

ECO-B. Ọkpụrụkpụ Njikwa Ọkpụrụkpụ nke Nkwakọ ngwaahịa Aluminom Foil: Ụkpụrụ Micron-Ọkwa na Ọdịiche Dị n'Ụdị-kpọmkwem

Ọkpụrụkpụ nke foil akụrụngwa ọgwụ a abụghị otu oke; ekwesịrị kewaa ya dabere na ọrụ chọrọ nke ọnọdụ ngwa ngwa akọwapụtara. A gbadoro isi nso n'etiti 5-50μm, na oke nhọrọ maka ọnọdụ dị iche iche ga-adakọrịrị “ọrụ mkpa” (arụmọrụ arụmọrụ / nkwado nhazi / arụmọrụ mgbochi):

(A) Ụkpụrụ ụlọ ọrụ na oke ịdị arọ zuru oke

Dị ka YBB si kwuo 00152023 na ISO 13028-2, isi ọkpụrụkpụ ranges na tolerances nke a pụrụ iche aluminum foil bụ ndị a:

Dee: Ụdị ọ bụla nke foil ọgwụ a na-akụnye ga-eji aluminom dị ọcha (1060-O ma ọ bụ 1100-O iwe) na ịdị ọcha nke n'elu 99.9%, na mkpokọta adịghị ọcha ọdịnaya (Fe+Si) ≤0.1% iji zere mmeghachi omume anụ ahụ nke mba ọzọ kpatara mgbasa in vivo.

(B) Nkọwapụta-kpọmkwem nhọrọ nhọrọ ịdị arọ

1. Ọnọdụ mgbanwe ịwa ahụ pere mpe (E.G., mkpuchi foil maka intravascular ọgwụ-eluting stent):

Ịkụnye ihe na-achọ ịfefe site na microcatheter nwere dayameta ≤2mm, ya mere, ọkpụrụkpụ nke a pụrụ iche foil ga-achịkwa n'etiti 8-15μm. Ọ bụrụ na ọkpụrụkpụ karịrị 20μm, n'ozuzu elu dayameta nke stent na-abawanye (Mmụba 10μm ọ ​​bụla na ọkpụrụkpụ foil na-eduga na mmụba ihe dịka 8μm na dayameta mpụta stent.), gafere oke dayameta dị n'ime nke microcatheter (E.G., Dayameta dị n'ime nke catheter 2F bụ ihe dịka 0.67mm), na-eme ka ọ ghara ikwe omume ịgafe akụkụ stenotic nke akwara obi. Ke ozo, foil dị oke oke na-ebelata ọnụego mkpirisi radial nke stent (ọnụego nkwekọrịta ≤30% na ọkpụrụkpụ 25μm, tụnyere ≥50% na <15μm ọkpụrụkpụ), ọzọ na-emetụta mmetụta appposition mgbe etinyere ya.

2. Ihe ndapụta ntọhapụ ọgwụ n'okpuru akpụkpọ ahụ (E.G., foil-polymer mejupụtara micropumps):

Dị ka ihe nhazi nke ụlọ nchekwa ọgwụ, Foil ọgwụ a na-etinyerịrị ga-edozirịrị ihe mgbochi yana mgbanwe, na ọkpụrụkpụ nso nke 10-25μm. Mgbe ọkpụrụkpụ bụ <10μm, ọnụego nnyefe oxygen karịrị 0.1cm³/(M² · 0h · 0.1MPA), na-eduga ná mbibi oxidative nke ọgwụ (E.G., >20% mfu nke ọrụ na ọgwụ protein n'ime 30 ubochi). N'ụzọ dị iche, mgbe ọkpụrụkpụ karịrị 25μm, Mgbanwe mgbanwe nke micropump na-ebelata (Ehulata akụkụ na-ebelata site na 120° ruo 60°), na mmebi anụ ahụ subcutaneous (omimi mmerụ ahụ epidermal >50μm) o yikarịrị ka ọ ga-eme n'oge ntinye.

3. Ọnọdụ nchekwa maka sensọ enwere ike ịkụnye (E.G., foil electromagnetic n'ígwé maka ụbụrụ-kọmputa interface):

Achọrọ iguzogide corrosion nke mmiri ahụ na nnyonye anya elektrọn, ya mere, ọkpụrụkpụ nke a pụrụ iche foil ga-achịkwa n'etiti 15-30μm. Mgbe ọkpụrụkpụ bụ <15μm, na electromagnetic shielding irè (SE) ibu <40dB, na-agaghị egbochi nnyonye anya mgbaàmà electromagnetic n'ime na n'èzí ahụ (E.G., mkpọtụ electromagnetic n'oge nyocha MRI). Ozoro, mgbe ọkpụrụkpụ karịrị 30μm, mkpokọta arọ nke ihe mmetụta na-abawanye (Mmụba 10μm ọ ​​bụla na-agbakwụnye 2.7mg kwa centimita square), na-eduga ná mkpakọ anụ ahụ na saịtị ntinye (nrụgide mkpakọ >3kpa, gafere oke nnabata nke anụ ahụ dị nro).

ECO-C. Mmetụta na-adịghị mma nke nkwakọ ngwaahịa aluminom dị oke oke na ịdị mma ịkụnye ihe.: Nyocha sitere na Mechanical na Arụ Ọrụ

Mgbe ọkpụrụkpụ nke foil akụrụngwa ọgwụ a karịrị oke oke nke ọnọdụ dabara adaba (E.G., >20μm maka ịwa ahụ nke pere mpe, >25μm maka ntinye subcutaneous), ọ na-ebelata ịdị mma ọrụ na akụkụ atọ: “ngwaọrụ formability,” “mgbanwe ntinye,” na “ndakọrịta postoperative.” Enwere ike ịchọpụta mmetụta ndị akọwapụtara site na data ọnụọgụ yana ụdị igwe:

(A) Ihe isi ike na-abawanye na imepụta ngwaọrụ yana mbelata nkenke

1. Mbelata ike nke microfabrication:

Maka foil oke oke (E.G., >30μm), “etching na-enweghị isi” na-eme n'oge a na-egwupụta oghere laser nke oghere ntọhapụ ọgwụ (oghere oghere 50-100μm)- perpendicularity mgbidi oghere na-ebelata site na 90 ° ruo 75 °, na elu burr na nsọtụ oghere karịrị 5μm, na-emezughị ihe achọrọ nke USP <1059> maka usoro nnyefe ọgwụ (agba ≤2μm). Ke ozo, ọnụ ọgụgụ stamping akpụ nke foil oke oke na-ebelata (akpụ iru eru ọnụego bụ 98% na 20μm ọkpụrụkpụ, ịdaba na 82% na 35μm), na wrinkles (omimi nke wrinkle >3μm) o yikarịrị ka ọ ga-etolite, na-ebute mkpuchi ọgwụ na-enweghị isi.

2. Oke mgbakọ nnabata:

Ịwere katrijị ọgwụ a na-akụnye dị ka ihe atụ, mgbe a na-eji foil pụrụ iche a na-eme ihe dị ka oyi akwa njikọ n'etiti ihe mkpuchi mkpuchi na ntọala polymer, 5μm ọ bụla na-abawanye na ọkpụrụkpụ ya na-eduga na mmụba 3μm na oghere njikọ (gafere ISO 80369-7 akara oghere ọkọlọtọ nke ≤5μm). Nke a na-eme ka ọnụ ọgụgụ ntapu ọgwụ na-abawanye site na <0.1μg / ụbọchị ruo >1μg / ụbọchị, gafere oke ntapu akọwapụtara na Ihe chọrọ nka maka sistemụ nnyefe ọgwụ nwere ike ịkụnye (YY/T 0983).

(B) Mmụba Mgbochi Ịkụnye na Ọgba aghara dị elu

1. Mwapu na ntupu na ịkwanye nguzogide:

Dị ka usoro ihe eji arụ ọrụ mmiri si dị (F=μ×A×v/d, ebe μ bụ ọnụọgụ esemokwu nke anụ ahụ, A bụ mpaghara kọntaktị foil, v bụ ọsọ na-agba, na d bụ ​​dayameta ngwaọrụ), n'otu ntabi anya ọsọ (1mm/s), Mgbe ọkpụrụkpụ foil na-abawanye site na 15μm ruo 30μm, dayameta elu ngwaọrụ na-abawanye site na 16μm, na nkwụsi ike na-ebilite site na 0.5N ruo 1.2N (gafere oke ike ime ihe ike nke 0.8N maka ndị ụlọ ọgwụ). Nke a na-ebute nhịahụ mgbidi vaskụla ngwa ngwa (ọkọ omimi >10μm, na-akpalite hyperplasia ime ime).

2. Mbelata ngbanwe mgbanwe na ngbanwe ọrụ:

Isi ike na-ehulata (D=Mba, ebe E bụ modulus na-agbanwe agbanwe na m bụ oge inertia) nke foil a na-etinye ọgwụ na-adaba na cube nke ọkpụrụkpụ ya (M ∝t³). Mgbe ọkpụrụkpụ na-abawanye site na 20μm ruo 40μm, isi ike na-ehulata na-abawanye site 8 ugboro, na-eduga na mmụba nke kacha nta na-ehulata radius nke ngwaọrụ site na 5mm ruo 15mm. Nke a na-eme ka ọ ghara ikwe omume ịgafe site na ọwa ntinye nke akụkụ ndị gbara agba dịka ikpere na nkwonkwo ụkwụ, na-abawanye oge ịwa ahụ (nkezi ndọtị nke 20 nkeji) na ihe ize ndụ ikpughe radieshon.

(C) ndakọrịta anụ ahụ mgbe arụchara arụrụala dara

Foil dị oke oke (>30μm) nwere mbelata kpọmkwem ebe elu (elu ebe/olu) (site na 5000cm²/cm³ ruo 2500cm²/cm³), na-ebelata ọnụ ọgụgụ mkpuchi anụ ahụ (ọnụego encapsulation bụ naanị 60% na 4 izu mgbe ịwachara ahụ, atụlere yana 90% maka 20μm-oke foil) na mfe ịkpalite mmeghachi omume mkpali na-adịghị ala ala. O doro anya, akụkụ anụ ahụ na-egosi na omimi infiltration nke mkpụrụ ndụ mkpali (E.G., macrophages) gburugburu foil oke oke ruru 100μm, ebe ọ bụ naanị 30μm na nkịtị ọkpụrụkpụ otu, na-agbaso ụkpụrụ nzaghachi mkpali nke ISO 10993-6 (Greedi 2 maka otu oke oke oke, Greedi 0 n'ihi na nkịtị ọkpụrụkpụ otu).

Elo-d. Mmebi a na-akpata site na nkwakọ ngwaahịa aluminom dị oke mkpa na-eme ka ọ bụrụ ihe ntọhapụ na-adịgide adịgide yana na nguzogide nrụgide Vivo.

Mgbe ọkpụrụkpụ nke foil pụrụ iche dị n'okpuru oke ala nke ọnọdụ dabara adaba (E.G., <5μm maka ihe mgbochi n'ígwé, <25μm maka nkwado nhazi), arụmọrụ ọdịda emee n'ihi “ezughị ezu n'ibu Njirimara” na “mbibi nke iguzosi ike n'ezi ihe.” Enwere ike ịchọpụta ihe egwu dị iche iche site na nnwale igwe ihe yana nnwale simulation vivo:

(A) Akwụsịghị ntụkwasị obi nke usoro ntọhapụ na-adịgide adịgide: Site na mwepụta ọgwụ ọjọọ ruo na mgbaji ụgbọ

1. Mmụba dị ukwuu n'ihe egwu ntọhapụ ọgwụ:

Mgbe foil dị oke mkpa (<8μm) a na-eji dị ka onye na-ebu maka microspheres na-ahapụ ya, ike ike ya na-agbada site na 120MPa ruo 80MPa (n'okpuru opekempe chọrọ 100MPa na YBB 00152023). Mgbawa (mgbape obosara >5μm) na-etolite ngwa ngwa n'oge ndochi ọgwụ (ndochi nrụgide 0.3MPa), na-eduga na ntọhapụ ọgwụ. Nnwale ntọhapụ in vitro na-egosi na ọnụego mwepụta ọgwụ awa 24 na-abawanye site na nke nkịtị 10% ka 45%, gafere oke ntọhapụ (≤20%) maka usoro mwepụta na-adịgide adịgide akọwapụtara na USP <1724>.

2. Ọdịda ngwaọrụ kpatara mgbajijiri ebu:

N'ihi na foil dabeere na-akwọ ụgbọala akpụkpọ anụ nke implantable ọgwụ nfuli (e mere ọkpụrụkpụ 15μm), ma ọ bụrụ na ọkpụrụkpụ na-ebelata ka 10μm, ndụ ike ọgwụgwụ ya na-agbada site na okirikiri 10⁶ ruo 3×10⁵ okirikiri (n'okpuru ọrụ afọ 5 chọrọ maka ngwaọrụ etinyere, nke na-achọ 1.8 × 10⁶ cycles dabere na 100 arụ ọrụ kwa ụbọchị). Mgbaji na-apụta 1 afọ postoperatively, na-egbochi mwepụta ọgwụ nkịtị ma chọọ ịwa ahụ nke abụọ maka iwepụ.

(B) Ọnwụ nke Nguzogide nrụgide Vivo: Site na nrụrụ arụrụ arụ ruo na ndakpọ zuru oke

Nrụgide na-adịgasị iche iche n'akụkụ dị iche iche nke ahụ (ọbara mgbali elu 120/80mmHg≈16kPa, subcutaneous anụ ahụ mgbali 3-5kPa, eriri afọ lumen mgbali 5-10kPa). Mpempe akwụkwọ dị oke mkpa enweghị ike iguzogide nrụgide ndị a, ya na ngosipụta akọwapụtara dị ka ndị a:

1. Ọnọdụ intravascular: Nhazi ndakpọ na-egbochi ọwa ọgwụ

Ọ bụrụ na mkpuchi foil nke ọgwụ-eluting stent (e mere ọkpụrụkpụ 12μm) na-ebelata ka 8μm, ọnụego nrụrụ radial nke foil na-abawanye site na 5% ka 25% n'okpuru nrụgide systolic arterial (16kpa) (dị ka usoro nrụgide ihe nkiri dị mkpa σ = p × r / t, ebe σ bụ nrụgide, p bụ nrụgide, r bụ stent radius, na t bụ foil ọkpụrụkpụ). Nke a na-akpata ngọngọ nke oghere ntọhapụ ọgwụ (dayameta 50μm) (nkwụsịtụ ọnụego >60%), na in-stent restenosis ọnụego na-abawanye site na 5% ka 20%.

2. Ọnọdụ subcutaneous: Mgbochi oyi akwa na-akpata ntinye mmiri nke ahụ

Ọ bụrụ na foil mgbochi oyi akwa nke katrij ọgwụ subcutaneous (e mere ọkpụrụkpụ 10μm) na-ebelata ka 5μm, ọnụego nnyefe oxygen ya na-abawanye site na 0.05cm³/(M² · 0h · 0.1MPA) ruo 0.2cm³/(M² · 0h · 0.1MPA). Oburu, pinholes (oghere >2μm) na-etolite n'okpuru nrụgide subcutaneous (5kpa), na-ekwe ka mmiri ahụ banye n'ime katrij ma kpatara mmebi ọgwụ (E.G., >30% mbelata ike insulin n'ime 30 ubochi).

3. Ihe atụ nke eriri afọ: Mgbasa ihe owuwu na-akpata ihe egwu ahụ si mba ọzọ

Ọ bụrụ na foil kpuchie nke ihe implantable eriri afọ ọgwụ nnyefe usoro (e mere ọkpụrụkpụ 30μm) na-ebelata ka 20μm, ọnụ ọgụgụ ndakpọ nke etiti na-eru 30% n'okpuru eriri afọ lumen mgbali (10kpa) (tụnyere naanị 5% na nkịtị ọkpụrụkpụ otu). Iberibe foil gbasasịrị (nha 5-10μm) nwere ike imebi mucosal eriri afọ, na-ekwekọ na “ihe ize ndụ nke mba ọzọ nwere ike ime” ọkwa nke ISO 10993-1 (Udi 2 maka otu dị oke mkpa, Udi 0 n'ihi na nkịtị ọkpụrụkpụ otu).

Eco-e. Atụmatụ kachasị mma maka nkwakọ ngwaahịa aluminom: Ịhazi arụmọrụ na ihe achọrọ

Iji lebara esemokwu ndị bụ isi nke njikwa ọkpụrụkpụ, A ghaghị ịtụpụta ihe ngwọta site na akụkụ atọ: “mgbanwe ihe,” “nhazi nhazi,” na “Usoro mmezi usoro” iji nweta mmekọrịta n'etiti “ịhịa aka n'ahụ” na “arụmọrụ dị elu” nke a ọgwụ implant foil:

(A) Mgbanwe ihe: Ịkwalite Njirimara Mechanical nke obere foil

1. Microalloying ike: Na-agbakwụnye 0.1-0.2% Zr (zirconium) ka elu-ọcha aluminum ụdị Al₃Zr dispersoids, na-abawanye ike tensile nke 8μm-oke foil site na 80MPa ruo 120MPa ka ị na-ejigide elongation nke 15%, izute ihe nkwado ihe owuwu chọrọ. Ke ozo, mgbakwunye Zr na-ebelata ọnụego mgbasa in vivo nke foil (site na 0.5μg/cm²·ụbọchị ruo 0.1μg/cm²·ụbọchị), na-erube isi na oke adịghị ọcha nke USP <232>.

2. Usoro ọgwụgwọ okpomọkụ kachasị mma: Inweta a “obere okpomọkụ annealing (150℃ × 2h) + oyi na-atụgharị (30% mbelata)” Usoro na-abawanye ndụ ike ọgwụgwụ nke 10μm-oke foil site na okirikiri 5 × 10⁵ ruo 1.2 × 10⁶ okirikiri., na-ezere agbaji agbaji mgbe etinyere ya.

(B) Nhazi nhazi: Dochie otu foil n'ụdị ihe mejupụtara

1. Foil-polymer composite oyi akwa: A mejupụtara Ọdịdị nke “5μm pụrụ iche foil + 10μm PEEK (polyethylene ketone)” dochie omenala 20μm dị ọcha aluminum foil. Ihe owuwu ihe mejupụtara ya nwere ike ndọtị nke 180MPa (1.5 ugboro nke dị ọcha foil), radius na-ehulata belata ruo 3mm (na-eme mgbanwe na ọwa obere mbuso agha), yana ọnụego nnyefe oxygen ≤0.03cm³/(M² · 0h · 0.1MPA), nke etinyere n'ọgbọ ọhụrụ nke stent na-ekpochapụ ọgwụ.

2. Nhazi nkwado mmanụ aṅụ: A na-eji etching laser na-emepụta obere ihe eji emepụta mmanụ aṅụ (oghere oghere 10μm, oghere oghere 5μm) n'elu nke a ọgwụ implant foil. Nke a na-abawanye ike mkpakọ radial nke foil 15μm-oke site na 10kPa ruo 25kPa., na-enyere ya aka iguzogide ọbara mgbali elu (16kpa), mgbe ị na-ebelata ibu site 20% na ibelata ihe egwu mkpakọ anụ ahụ.

(C) Usoro mmezi usoro: Imelite ịdị n'otu na nkenke ịdị arọ

1. Usoro mpịakọta nke ọma: Iji igwe igwe na-atụgharị oyi dị elu 20 (ike mpịakọta 500kN, ọsọ 100m/min) na-ebelata oke nnabata nke foil pụrụ iche site na ± 1.0μm ruo ± 0.5μm, na-ezere oke oke oke ma ọ bụ mkpa. Oburu, “online laser ọkpụrụkpụ nha” (nlele ugboro 1000Hz) a na-eji n'oge mpịakọta iji mezie paramita mpịakọta ozugbo, nweta a ọkpụrụkpụ uniformity nke 95% (atụlere yana 85% na usoro omenala).

2. Usoro trimming ọnụ mgbe nhazi gasịrị: Plasma etching (ike 500W, Etching ọsọ 5mm/s) a na-eji ewepu burrs site na nsọtụ foil (na-ebelata site na 5μm ruo 1μm), n'ịhụ na ọ dịghị akpụkpọ anụ n'oge ịkụnye.

Eco-f. Mmechi

The ọkpụrụkpụ akara nke Nkwakọ ngwaahịa aluminom foil ga-esochi ya Micron-larịị nso nke 5-50μm, na ọkpụrụkpụ nke kewara ekewa (8-15µm/5-15µm/25-50µm) dabere na ndapụta dị ka “mmegharị nke ịwa ahụ nke pere mpe,” “ihe mgbochi ntọhapụ kwadoro,” na “nkwado ihe owuwu.” Foil dị oke oke na-emetụta ịdị mma ịkụnye ihe site na ịba ụba nguzogide ọrụ, ibelata mgbanwe, na ndakọrịta anụ ahụ na-emebi emebi; foil dị oke mkpa nke ukwuu na-akpata enweghị ntụkwasị obi nke ụlọ ntọhapụ na-adịgide adịgide yana ọdịda nke nguzogide nrụgide in vivo n'ihi akụrụngwa akụrụngwa zuru oke.. N'ọdịnihu, site na synergistic ọhụrụ nke “ihe microalloyed + nhazi nhazi ihe mejupụtara + usoro ntụgharị nke ọma,” Enwere ike ibelata oke nso nke foil pụrụ iche (E.G., 3-30μm) iji nweta ọganihu nke “ọkpụrụkpụ ọkpụrụkpụ + arụmọrụ dị elu,” na-akwalite mmepe nke ngwaọrụ ahụike na-akụnye n'ebe “opekempe na-akpa ike na ogologo oge” ngwọta.

Isi Ụkpụrụ: Nhọrọ ọkpụrụkpụ nke foil ọgwụ a na-akụnye ọgwụ bụ n'ezie itule triangular nke “ọrụ chọrọ – n'ibu Njirimara – arụmọrụ mma.” Ọ ghaghị ịdabere na ụkpụrụ ụlọ ọrụ, jikọtara ya na gburugburu nrụgide nke ebe a na-etinye ihe ọkụkụ na nha nke ọwa na-arụ ọrụ, na kpebisiri ike site quantitative mgbako (E.G., na-ehulata isi ike, ụdị nrụgide-deformation) iji zere nhọpụta pụtara ìhè.